Status:
COMPLETED
Hypotonic Versus Isotonic Parenteral (HIP) Fluid Trial
Lead Sponsor:
Hamilton Health Sciences Corporation
Conditions:
Hyponatremia
Hypernatremia
Eligibility:
All Genders
6-16 years
Phase:
PHASE3
Brief Summary
Children who are undergoing surgery need intravenous fluids to prevent dehydration and maintain their electrolyte balance. The current standard of care in these children is to use a fluid which is low...
Detailed Description
Research Question: In general pediatric surgical patients, do isotonic PMS compared to hypotonic PMS, result in a lower risk of acute hospital acquired plasma sodium derangements, occurring at any ti...
Eligibility Criteria
Inclusion
- Pediatric patients, 6 months corrected age -16 years, undergoing surgery.
- Within 6 hours of the immediate post-operative period.
- Post-operative stay anticipated to be more than 24 hours.
- Primary route of fluid administration is anticipated to be intravenous, in the first 24 hours following surgery.
- Informed consent of parent/guardian.
- Consent to participate from surgeon.
Exclusion
- Patients under 6 months of age
- Patients equal to or over 17 years of age
- Patients with hemodynamic instability , defined as a requirement for continuous vasoactive infusion (e.g. epinephrine, dopamine, norepinephrine, phenylephrine, milrinone, or Dobutamine) to maintain blood pressure at the end of surgery.
- Patients admitted into the "short stay" post-operative unit
- Patients in whom either hypotonic or isotonic solutions may be contraindicated/necessary: i.e. specific neurosurgical patients (ie those at risk of increased ICP, e.g. requiring actual brain surgery, ICP monitor or external ventricular drain insertion), patients with diabetic ketoacidosis, acute (≤ 7 days) burns, pre-existing CHF, liver failure or cirrhosis, renal failure.
- Patients with known pre-existing risk of PNa derangements: DI or SIADH
- Chronic diuretic use - defined as use of any oral or intravenous diuretics for ≥ 7 days.
- Known, uncorrected PNa derangement (PNa \< 134 or \> 146 mmol/L), identified peri-operatively (i.e. within 12 hours of surgery or during surgery).
- Prior enrolment in this study
- Patients or their guardians objecting to give consent.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT00734214
Start Date
March 1 2008
End Date
December 1 2009
Last Update
April 29 2015
Active Locations (1)
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1
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5